Our Solutions

The right CRO for your preclinical and clinical biosimilar studies

Companies developing biosimilars are collaborating with us because of our firsthand preclinical and clinical experience, distinctive recruitment strategies and speed in conducting biosimilar studies that require a customized approach based on the therapeutic indication and study-specific goals.

We have the scientific, toxicological, medical, and bioanalytical know-how to design studies that meet your objectives and timelines, manage any associated risks, and develop the methods required to analyze your product and its potential immunogenicity.

How we help move your biosimilar programs forward:

arrow

Customized workflows using LC-MS/MS or Ligand Binding bioanalytical platforms for preclinical and clinical samples

arrow

Method development, GCP/GLP-compliant biosimilar assay development validation, and sample analysis for PK and immunogenicity/anti-drug antibody testing

arrow

Comparative general toxicity and PK studies in multiple species

arrow

Supplemental assessments such as for immunogenicity can be included in general toxicology study designs or as individual projects, depending on the nature of the test article

arrow

Ability to run multiple biosimilar programs simultaneously across our three clinical pharmacology units

arrow

Rapid recruitment and retention of up to 250 subjects per clinical pharmacology trial

arrow

Pharmacodynamic assessments required for biosimilars ranging from measurements in blood to performing glucose or insulin clamps

View our issue of The Altascientist on the topic and contact one of our experts to learn how we can help with your biosimilar programs.

BOOK A CONSULT

THERAPEUTIC AREAS

Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.

Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.

Learn More